International News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Device experts set sights on GHTF: European Commission's Medical Devices Experts Group will discuss the preparation of the EC's 2004-2006 Global Harmonization Task Force chairmanship during Oct. 27-28 Brussels meeting. Eucomed Director General Maurice Wagner will serve as vice-chairman (1"The Gray Sheet" June 30, 2003, p. 9). Also on the agenda are reclassification of total joint implants and reports from Study Group 2, which specializes in adverse event reporting. During SG2's Aug. 27-28 meeting, Chair Carol Herman updated the progress of an adverse event coding tool and a proposal to consolidate all adverse event reporting documents for manufacturers...
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International News In Brief
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Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.